Quinagolide, sold under the brand name Norprolac, is a selective dopamine D₂ receptor agonist which is used to manage hyperprolactinemia. It has also been found to be effective in the treatment of breast pain. It is used in the UK, but it is not available + some more technical info Quinagolide is an orally active, non-ergot D2-preferring agonist with high in vitro affinity for dopamine D2 receptors and a pharmacokinetic profile compatible with once-daily administration; it is absorbed from the gastrointestinal tract, undergoes extensive hepatic metabolism with renal elimination of metabolites, and produces prolactin suppression by direct D2 receptor-mediated inhibition of pituitary lactotroph secretion. For development and quality control, assay and content uniformity are performed using validated HPLC or LC-MS methods and stability is established through forced-degradation studies; clinical use requires dose titration under medical supervision because of dopaminergic adverse effects and potential interactions with drugs affecting dopaminergic or cytochrome P450 pathways.
Typical impurity control for quinagolide drug substance and finished product defines individual specified impurities commonly limited to the range 0.1 to 0.5 percent w/w and total impurities limited to about 1.0 percent w/w or less, with reporting thresholds for unidentified impurities down to 0.05 to 0.1 percent in line with ICH Q3A principles; tighter limits may be applied to genotoxic or structurally similar degradants. Forced-degradation and stability studies generally reveal related substances such as N-dealkylated species, N-oxide metabolites, hydroxylated derivatives and minor ring-modified products, and these are monitored and quantified by stability-indicating gradient HPLC with LC-MS confirmation and NMR structure elucidation where needed. Residual solvents and elemental impurities are controlled per ICH Q3C and Q3D and acceptance criteria are defined in the product specification with validated analytical procedures for release and stability testing.
Quinagolide is used to treat hyperprolactinemia by lowering elevated serum prolactin and alleviating related symptoms such as menstrual disturbance, infertility and breast pain; it is prescribed and titrated by clinicians based on clinical response and tolerability.
Yes, quinagolide is a selective dopamine D2 receptor agonist that reduces prolactin secretion from pituitary lactotrophs via D2 receptor activation.
Quinagolide is sold under the brand name Norprolac.
